TUBING SYSTEM FOR PLASMAPHERESIS

GUDID 18855036020688

Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The L

KANEKA PHARMA AMERICA LLC

Apheresis system tubing set Apheresis system tubing set
Primary Device ID18855036020688
NIH Device Record Key083f36ab-173d-4a6d-9fde-027d3b86beb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTUBING SYSTEM FOR PLASMAPHERESIS
Version Model NumberNK-M3R(UL)
Company DUNS136605362
Company NameKANEKA PHARMA AMERICA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005263521
Emailinfo@liposorber.com
Phone8005263521
Emailinfo@liposorber.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *In transporting and storing the disposable, handle with care and store in a clean and secure area, avoiding exposure to direct sunlight, high humidity or excessive vibration.
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *In transporting and storing the disposable, handle with care and store in a clean and secure area, avoiding exposure to direct sunlight, high humidity or excessive vibration.
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS118855036020688 [Primary]
GS128855036020685 [Package]
Package: Outer Box [6 Units]
In Commercial Distribution

FDA Product Code

PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-21
Device Publish Date2018-08-21

On-Brand Devices [TUBING SYSTEM FOR PLASMAPHERESIS]

18855036020688Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable de
18855036012850Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable de

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